Roche, Spark push back takeover deadline in $4.3 billion deal

Swiss drugmaker Roche (ROG.S) has agreed to extend the takeover deadline in its $4.3 billion bid for U.S. gene therapy specialist Spark Therapeutics (ONCE.O), adding it remains “fully committed” to the transaction and expects it to close this year.

The new deadline for both companies to extend the merger agreement now runs to April 30, 2020, rather than Jan. 31, 2020, Roche said in a U.S. regulatory filing on Monday, saying the change provides “additional time to clear the transaction”.

“Although closing this deal is taking longer than I had hoped, my excitement about our anticipated partnership has only increased,” Roche Chief Executive Severin Schwan wrote in a note to Spark employees that was published by the U.S. Securities and Exchange Commission. “While we still expect this transaction to close in 2019, we want to ensure that we proactively identify and remove any potential future obstacles to achieving this outcome.”

https://www.reuters.com/article/us-spark-m-a-rochehldg/roche-spark-push-back-takeover-deadline-in-4-3-billion-deal-idUSKCN1U31HZ

Lannett In Distribution Agreement For Levothyroxine

Lannett Company, Inc. (NYSE: LCI) today announced that it has entered into a future exclusive supply and distribution agreement for the approved Levothyroxine Sodium Tablets USP of Cediprof, Inc., a wholly owned subsidiary of privately held Neolpharma Pharmaceutical Group.

Under the agreement, Lannett will commence U.S. distribution of the product no later than August 1, 2022. Lannett will make an upfront payment of $20 million within the next five business days and will receive a portion of the net profits once it commences distribution of the product. The term of the agreement is 10 years, which begins upon commencement of distribution. Other terms were not disclosed.

“The Levothyroxine product covered under the agreement includes all 12 currently marketed dosage strengths, is FDA approved and presently commercialized by another party,” said Tim Crew, chief executive officer of Lannett. “We know well the market dynamics for Levothyroxine, and look forward to re-entering the space, especially with Cediprof’s high quality product. Levothyroxine is one of the most widely prescribed drugs in the U.S. and continues to be a critically important medication for thyroid deficiency.”

https://www.biospace.com/article/releases/lannett-enters-into-distribution-agreement-for-levothyroxine/

Replimune started at Buy by Wainwright

Target $26

https://www.benzinga.com/stock/REPL/ratings

Array cut to Neutral from Overweight by Cantor

Target to $48 from $34

https://www.benzinga.com/stock/ARRY/ratings

Amneal upped to Overweight from Neutral by Piper

Target $11

https://www.benzinga.com/stock/AMRX/ratings

Catalyst Bio’s MarzAA successful in mid-stage hemophilia study

A Phase 2 trial of Catalyst Biosciences’ (NASDAQ:CBIO) subcutaneous (SQ) Factor VIIa (FVIIa) variant marzeptacog alfa (activated) (MarzAA) for prophylaxis met the primary endpoint of significantly reducing the annualized bleed rate (ABR) in patients with hemophilia A or B with inhibitors.

The study also met all secondary endpoints of safety, tolerability and lack of anti-drug antibody or inhibitor formation.

Daily SQ administration for 50 days at an individual’s final dose of MarzAA significantly reduced the mean 6-month pre-study ABR from 19.8 to 1.6 and Proportion of Days with Bleeding (PDB), from 12.3% to 0.8%, during treatment.

The median ABR and PDB were both reduced to zero.

The Company will host a conference call today, at 8:00 a.m. EDT to discuss the MarzAA and DalcA data.

Shares are down 2% premarket.

https://seekingalpha.com/news/3476090-catalyst-bios-marzaa-successful-mid-stage-hemophilia-study

Aytu Bio up 8% premarket on encouraging Natesto data

Aytu BioScience’s (NASDAQ:AYTU) study titled, Efficacy of Nasal Testosterone Gel (Natesto) Stratified by Baseline Endogenous Testosterone Levels, achieves similar symptom improvement, regardless of the degree of patients’ testosterone deficiency, while maintaining function of the Hypothalamic-Pituitary-Gonadal (HPG) axis in hypogonadal men.

The Phase 3 study enrolled 306 patients, who were treated with Natesto for up to one year. Each dose of Natesto resulted in a short-term return of testosterone to the upper normal range (800 ng/dL) irrespective of how low the patient’s baseline testosterone was prior to the study.

A mean average serum testosterone level of 295 ng/dL was achieved, in patients with the lowest baseline testosterone level.

Statistically significant improvements in symptom relief (erectile function, mood and lean body mass) were observed in these patients.

Shares are up 8% premarket.

https://seekingalpha.com/news/3476110-aytu-bio-8-percent-premarket-encouraging-natesto-data